NA XL-HDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384010630), received between Feb 22, 2019 and Apr 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

35 other recalls cover devices cleared under the same FDA submission (K080802); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE ATTACHMENT DEVICE WAS OVERHEATING. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616622 ↗
• MalfunctionFeb 22, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE CUTTER DEVICE WAS JAMMED IN THE ATTACHMENT AND MOTOR DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE OVERHEATED, THE COLOR RING ON THE NOSE CONE WAS DISCOLORED AND THE BEARINGS WERE WORN OUT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080802. One submission often covers many models, so check the product and lot details in each record.

• Z-1949-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-1957-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, no irrigation
• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-1956-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, with irrigation Product Usage: Electric system
• Z-1948-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction Switch Product Usage: Electric system
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric system
• Z-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS Product Usage: Electric system
• Z-0727-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM C
• Z-0729-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and
• Z-0728-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine

…and 20 more.